FDA Clears the Quest Diagnostics Simplexa® C. difficile Mole... (M. Lieberman M.D. medical director infec...)

FDA Clears the Quest Diagnostics Simplexa® C. difficile Molecular Test

Date:4/11/2012

M. Lieberman, M.D., medical director, infectious disease, for Quest Diagnostics and Focus Diagnostics. "Fast, reliable PCR tests that are highly specific and sensitive in the detection of the tcdB gene, a toxin-B producing gene of C. difficile, are essential for identifying and treating this infection as well as containing its spread."

With the FDA clearance, the Simplexa C. difficile Universal Direct Test on the 3M Integrated Cycler is immediately available in the United States. Focus Diagnostics launched the test in Europe during the second quarter of 2011.

About Simplexa®

Focus Diagnostics, a wholly-owned business of Quest Diagnostics, develops and manufactures the Simplexa line of molecular test products operating on the 3M™ Integrated Cycler, a compact, portable testing platform, as part of an exclusive global collaboration with 3M™. Simplexa was the first test kit to be FDA cleared for aiding in the detection and differentiation of the 2009 H1N1 influenza virus, in May 2010. Additional FDA-cleared Simplexa tests aid the detection of influenza A and B and respiratory syncytial virus. Several other Simplexa-branded tests, including for Clostridium difficile, Epstein Barr and BK viruses, are CE marked and distributed in Europe. In 2011, the Simplexa/3M technology won a gold Medical Design Excellence Award in the in vitro diagnostics category and an Edison Award for new science and medical diagnostic product.

To learn more about or to order Simplexa and other Focus Diagnostics tests, please contact Focus Diagnostics at 800-445-0185 (U.S.) or +49-6026-9499540 (Europe), or visit SimplexaDx.com or FocusDx.com.

About Quest Diagnostics

Quest Diagnostics is the world's leading provider of diagnostic testing, information and services that patients and doctors need to make better healthcare decisions. The company offers the broadest access to diag
'/>"/>

SOURCE Quest Diagnostics
Copyright©2010 PR Newswire.
All rights reserved

0

GOOD

Page: 1 2 3
Related medicine technology :

1. FDA Clears Advanced Test for Monitoring Metastatic Colorectal Cancer
2. FDA Clears ExAblate Fertility Enhancement Study in Women With Uterine Fibroids
3. FDA Clears the Pathwork(R) Tissue of Origin Test for Hard-To-Identify Tumors
4. U.S. Food and Drug Administration Clears Way for Multi-Center Clinical Trial of IDEV Technologies SUPERA Peripheral Stent
5. FDA Clears a Test for Ovarian Cancer
6. Private Investment Firm Czura Thornton Today Introduces Clearstone Central Laboratories as the Newest Member of the Czura Thornton Life Science Group
7. U.S. Food and Drug Administration Clears Alcatel-Lucent Remote Patient Monitoring Solution for Sale in the United States
8. FDA Clears the First Rapid Test to Detect Bacteria in Pooled Platelets
9. FDA Grants Cequent IND - Clears Way for First-Ever Clinical Trial of Orally Delivered RNAi Therapeutic: CEQ508, a tkRNAi Drug Candidate in Oncology
10. FDA Clears the Fenwal Amicus(R) Separator System for Collecting Platelets in New Additive Solution
11. FDA Clears Three Additional Antimicrobials for Use on TREK Sensititre(R) In Vitro Diagnostic (IVD) MIC Susceptibility Plates: Minocycline and Telavancin Used to Treat MRSA and Other Infections; and Tigecycline, Now Cleared for Streptococcus Pneumoni

Post Your Comments:

(Date:5/20/2013)... -- Life Technologies Corporation (NASDAQ: LIFE ... and 3500xL Dx Genetic Analyzers have been approved by ... Mexico for diagnostic use. The ... to serve the clinical end market in ... -based solutions. The Applied Biosystems™ 3500 ...

(Date:5/20/2013)... , May 20, 2013 Hyland ... healthcare industry by creating the Multi-Disciplinary Clinical Leadership ... variety of medical experts with diverse healthcare experience, ... healthcare industry to create new software solutions that ... specific needs of patients and staff. ...

(Date:5/20/2013)... May 20, 2013 Enrollment of patients with ... 2b dose-finding clinical trial of product candidate NewMet ... treatment for Type 2 diabetes. Elcelyx expects to complete ... in June. Results of the trial,s primary endpoint of ... summer, and the read-out for long-term glucose lowering and ...

Breaking Medicine Technology:Life Technologies Announces Regulatory Approval of 3500 Dx Series Genetic Analyzers in Mexico 2 Life Technologies Announces Regulatory Approval of 3500 Dx Series Genetic Analyzers in Mexico 3 Hyland Software Forms Multi-Disciplinary Clinical Leadership Team to Augment Healthcare Solutions 2 Elcelyx Therapeutics Enrolling Phase 2b Trial of NewMet for Type 2 Diabetes 2 Elcelyx Therapeutics Enrolling Phase 2b Trial of NewMet for Type 2 Diabetes 3 Elcelyx Therapeutics Enrolling Phase 2b Trial of NewMet for Type 2 Diabetes 4

[0] Life Technologies Announces Regulatory Approval of 3500 Dx Series Genetic Analyzers in Mexico [0] Hyland Software Forms Multi-Disciplinary Clinical Leadership Team to Augment Healthcare Solutions [0] Elcelyx Therapeutics Enrolling Phase 2b Trial of NewMet for Type 2 Diabetes

... Nov. 1, 2011 Champions Oncology, Inc. ... CSBR ) , a company engaged in the development ... development and use of oncology drugs, has appointed Gary ... Vice President and Chief Financial Officer. Joel Ackerman, the ...

... 1, 2011 Trend Micro Incorporated (TYO: 4704; TSE: ... commitment to the security of the nation,s critical healthcare ... Innovation, Safety and Security Consortium (MDISS). As ... Consortium in helping to protect public health and well-being ...

Cached Medicine Technology:Champions Oncology, Inc. Appoints Executive Vice President and Chief Financial Officer to Management Team and Corporate Office Relocation 2 Champions Oncology, Inc. Appoints Executive Vice President and Chief Financial Officer to Management Team and Corporate Office Relocation 3 Trend Micro Joins Industry Leaders in the Effort to Secure Critical IT Healthcare Infrastructure 2 Trend Micro Joins Industry Leaders in the Effort to Secure Critical IT Healthcare Infrastructure 3

Champions Oncology, Inc. Appoints Executive Vice President and Chief Financial Officer to Management Team and Corporate Office Relocation Trend Micro Joins Industry Leaders in the Effort to Secure Critical IT Healthcare Infrastructure

(Date:5/21/2013)... It took Willie Benitez, a heroin ... sixth time on a fifteen year sentence, six months ... to trust him enough to allow Willie to start ... “NarcoNon” Willie intended to name his “drug rehabilitation foundation,” ... and did start up that class. , Early ...

(Date:5/21/2013)... Leading New Jersey real estate agent, ... One of her favorite aspects of walkable places is ... light of the current childhood obesity epidemic that plagues ... walkable living. , A New York Academy of Sciences ... neighborhoods as a key combatant to obesity. The same ...

(Date:5/21/2013)... 2013 Dr. James C. Wittig, Chief ... the Sarcoma Division of the John Theurer Cancer Center ... been named one of the top 13 Orthopedic Oncologists ... Dr. Wittig is one of approximately 125 surgeons in ... created by surveying thought leaders in the field of ...

(Date:5/21/2013)... The Michigan Lupus Foundation will be holding a ... 11th. , Meeting Details: , Tuesday, June 11th , ... Room 5 (Lower Level), 1375 North Main Street, Lapeer, ... people with lupus and their family and friends to ... better understanding of this disease and how to fight ...

(Date:5/21/2013)... 21, 2013 Joe Vitale, a positive thinking ... adapter of the Fisker electric car. After a year and ... the car company went bankrupt, the bestselling author turned grumpy ... , "It's a gas guzzler's anthem," says Vitale, 59, who ... "Sun Will Rise." , Owning this Fisker was a ...

Breaking Medicine News(10 mins):Health News:Narconon Releases Report on its Very First Narconon Program, the First of 23 Reviews or Evaluations of Results up to 2009 2 Health News:Narconon Releases Report on its Very First Narconon Program, the First of 23 Reviews or Evaluations of Results up to 2009 3 Health News:Narconon Releases Report on its Very First Narconon Program, the First of 23 Reviews or Evaluations of Results up to 2009 4 Health News:Narconon Releases Report on its Very First Narconon Program, the First of 23 Reviews or Evaluations of Results up to 2009 5 Health News:New Jersey Realtor, Lina Panza, Advocates Walkable Neighborhoods to Combat Childhood Obesity 2 Health News:New Jersey Realtor, Lina Panza, Advocates Walkable Neighborhoods to Combat Childhood Obesity 3 Health News:James C. Wittig, MD, Selected as one of America's Top 13 Orthopaedic Oncologists 2 Health News:James C. Wittig, MD, Selected as one of America's Top 13 Orthopaedic Oncologists 3 Health News:Upset Fisker Owner Records Gas Guzzler Anthem 2

[0] Narconon Releases Report on its Very First Narconon Program, the First of 23 Reviews or Evaluations of Results up to 2009 [0] New Jersey Realtor, Lina Panza, Advocates Walkable Neighborhoods to Combat Childhood Obesity [0] James C. Wittig, MD, Selected as one of America's Top 13 Orthopaedic Oncologists [0] Lupus Support Group Meeting in Lapeer on June 11th [0] Upset Fisker Owner Records Gas Guzzler Anthem

... someday help control anxiety, experts say, , , FRIDAY, May 15 ... anxiety isn,t something associated with heights, a job interview or ... state of worry and tension that affects twice as many ... slowly eroding their quality of life. , But a new ...

... ORLANDO A pill used for nerve pain offers women ... 45th Annual Meeting of the American Society of Clinical ... hot flash severity and frequency about 20 percent more than ... the same benefit as gabapentin, an older, related drug, as ...

... in GI and Endoscopy Nursing at SGNA 36th Annual ... Nurses and Associates, Inc. (SGNA) is proud to honor ... awards that recognize their dedication to the field and ... distinguished awards represent the best in GI and endoscopy ...

... Palatin Technologies, Inc. (NYSE Amex: PTN ) announced ... Palatin reported net income of $0.1 million, or $0.00 per basic ... to a net loss of $5.1 million, or $0.06 per basic ... revenues in the quarter ended March 31, 2009 were $5.2 million, ...

... 15 /PRNewswire-Asia-FirstCall/ -- Shengtai,Pharmaceutical, Inc. (OTC Bulletin Board: ... distributor of high-quality, pharmaceutical grade,glucose products in China, ... of fiscal 2009 ended March 31, 2009. , ... has impacted our operations thus far in,fiscal year ...

... Dr. Bruno E. Gerber is recognized in ... is a Consultant Orthopedic Surgeon with a special ... of the lower limbs. He also is employed ... development project regarding innovative orthopedic laser treatment.Dr. Gerber ...

Fear Response May Stem From Protein in Brain Mayo Clinic researchers say agent provides treatment option for women with hot flashes SGNA Honors Outstanding Gastroenterology and Endoscopy Professionals With Nationwide Awards Palatin Technologies, Inc. Reports Fiscal Year 2009 Third Quarter Results; Teleconference and Webcast to be held on May 15, 2009 Shengtai Pharmaceutical, Inc. Reports Unaudited Third Quarter Fiscal 2009 Financial Results Continental Who's Who Executive Press Release: Dr. Bruno E. Gerber - Medical Professional

... The TOPCON OM-4 Ophthalmometer ... compactly designed and easy ... providing precise objective measurements ... of curvature plus accurate ...

... Based on the latest digital chip ... FA/Color System from Topcon features 3,072 x ... range for each color channel! The system ... also features real-time image acquisition, which facilitates ...

... Set offers a maximum selection ... corrected curve additive design that ... spacing between combined lenses. This ... be read directly from the ...

... power table has everything that you need ... new AIT-15 offers 20 mm of additional ... and locking castors to secure the table. ... for most any application. Use a double ...

Medicine Products:

Topcon OM-4 Ophthalmometer Topcon IMAGEnet 2000 FA/Color System with 3,072 x 2,048 pixels Topcon TLS-FD trial lens set AIT-15 instrument table